Clinical Comparison of Different Debonding Techniques of Clear Aligner Attachments: A Single-center, Split-Mouth Randomized Clinical Trial
| Registry | NCT07259642 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 32 (Actual) |
| Sponsor | Hacettepe University (Other) |
| Conditions | Orthodontic Pain (D013850), Orthodontic Patient Experience, Orthodontic Aligners, Orthodontic |
| Interventions | Adhesive removal plier followed by tungsten carbide bur, Tungsten carbide bur (Procedure) |
| Dates | start 2024-04-01, primary completion 2024-12-31, completion 2024-12-31, first posted 2025-12-02, last updated 2025-12-02 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Orthodontic Pain (D013850) All trials for Orthodontic Patient Experience All trials of Adhesive removal plier followed by tungsten carbide bur All trials of Tungsten carbide bur
The goal of this clinical trial is to compare two different methods for removing clear aligner attachments from tooth surfaces and to evaluate the pain levels and removal times associated with each method. The main questions this study aims to answer are:
* Does the use of an adhesive removal plier result in less pain compared to using a tungsten carbide bur?
* Is there a difference in the time required to remove attachments between the two methods?
In this split-mouth, randomized clinical trial, participants who have completed clear aligner treatment will undergo two different attachment removal techniques:
* Plier method: Attachments will be removed using adhesive removal pliers, followed by finishing with a tungsten carbide bur.
* Bur method: Attachments will be removed entirely using a tungsten carbide bur. Pain levels will be assessed using an 11-point Numeric Rating Scale (NRS) after each segment is treated, and the time required for each removal will be recorded. The amount of adhesive remaining on the enamel surface will also be evaluated.
This study aims to determine which debonding technique provides a faster and more comfortable experience for patients at the end of aligner treatment.
This study was conducted to compare two different debonding techniques used for removing clear aligner attachments and to evaluate their effects on pain perception, removal time, and adhesive remnants on the enamel surface. Clear aligner attachments are routinely used to enhance tooth movement, and their removal at the end of treatment should be efficient, safe, and comfortable for patients. However, there is limited clinical evidence evaluating patient-centered outcomes.
This single-center, split-mouth, randomized clinical trial included participants who had completed clear aligner treatment or the first set of clear aligners and required removal of composite attachments. Each participant received both debonding techniques in diagonally opposite quadrants to allow direct comparison within the same individual. In the plier technique, attachments were mechanically disengaged using adhesive removal pliers, followed by refinement of the enamel surface with a 24-blade tungsten carbide finishing bur. In the bur technique, attachments were completely removed using a 24-blade tungsten carbide bur without prior mechanical detachment. All procedures were performed at low speed and without water cooling.
Pain intensity was assessed immediately after debonding each segment using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate worse pain. Removal time for each attachment was recorded using a digital timer. Adhesive remnants were evaluated using a modified Adhesive Remnant Index (ARI) scored from 0 to 2. Additional analyses examined whether pain scores differed by age, gender, and attachment type (optimized vs. conventional).
The overall aim of this study was to provide clinically relevant evidence to guide orthodontists in selecting an attachment removal technique that maximizes patient comfort, improves clinical efficiency, and minimizes adhesive remaining on the enamel surface at the end of clear aligner therapy.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Plier group | Experimental | Procedure: Adhesive removal plier followed by tungsten carbide bur | In this group, clear aligner attachments are removed using adhesive removal pliers , followed by cleaning of residual adhesive with a 24-blade tungsten carbide finishing bur operated at low speed (20,000 rpm) without water cooling. |
| Bur Group | Active comparator | Procedure: Tungsten carbide bur | In this group, clear aligner attachments are completely removed using a 24-blade tungsten carbide bur operated at low speed (20,000 rpm) without water cooling. |
Sex: All, ages: 18 Years to 44 Years, accepts healthy volunteers
Inclusion Criteria: * Patients aged 18 to 44 years with permanent dentition * No history of taking medication in the last 24 hours (e.g., painkillers, corticosteroids, and antiflu drugs) * Patients with no missing teeth except for third molars * Patients who underwent clear aligner treatment (Invisalign®) without an extraction protocol by one of the co-authors of the present study * Patients who completed aligner treatment and reached the attachment removal stage * Patients with at least 4 attachments in each quadrant of the mouth and a total of at least 16 attachments * Patients in good general and oral health with no periodontal disease Exclusion Criteria: * Patients with endodontic treatment, large restorations, and buccal restorations * Patients with a history of previous orthodontic treatment * The presence of systemic diseases that may cause dentin and enamel hypersensitivity * Patients who underwent surgical treatment and displayed signs of gingival recession * Patients who received teeth whitening in the last 8 weeks.
| Facility | City | Country | Status |
|---|---|---|---|
| Hacettepe University Faculty of Dentistry Department of Orthodontics | Ankara | Turkey (Türkiye) |